Long Term Treatment With L-DOPS

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
David Robertson, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00889135
First received: April 24, 2009
Last updated: October 14, 2016
Last verified: October 2016

April 24, 2009
October 14, 2016
September 2004
June 2015   (Final data collection date for primary outcome measure)
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Less dizziness while in standing posture. [ Time Frame: 3 month intervals ]
Complete list of historical versions of study NCT00889135 on ClinicalTrials.gov Archive Site
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Long Term Treatment With L-DOPS
Long Term Treatment With L-DOPS
This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also allows us to collect medical history information on this small population of patients that would allow us to determine if there are any complications from this type of treatment.
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Expanded Access
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Dopamine Beta Hydroxylase (DBH) Deficiency
Drug: droxidopa
Droxidopa (L-DOPS) comes in capsule form, 100 mg or 200 mg strength and is usually administered 2 - 3 times per day. It would be taken indefinitely to improve symptoms of orthostatic hypotension
Other Names:
  • L-DOPS
  • DOPS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
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June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years old or older with orthostatic hypotension
  • established diagnosis of DBH deficiency and fractionated plasma catecholamine levels that show high dopamine levels and very low norepinephrine and epinephrine levels. Blood pressure increase in response to oral treatment with L-DOPS during previous studies.

Exclusion Criteria:

  • subjects with orthostatic hypotension that do not have a genetic form of the disorder and catecholamine pattern is not consistent with that above.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00889135
041037
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David Robertson, Vanderbilt University
Vanderbilt University
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Principal Investigator: David Robertson, M.D. Vanderbilt University Medical Center
Vanderbilt University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP